PMA P010038S016

Device
SECONDLOOK DIGITAL V7.2 CAD
Applicant
Icad, Inc.
PMA number
P010038
Supplement
S016
Product code
MYN
Decision date
2012-11-09
Generic name
Analyzer, medical image
Approval order statement
APPROVAL FOR THE SECONDLOOK DIGITAL V7.2 CAD FOR USE WITH THE PHILIPS MICRODOSE FULL-FIELD DIGITAL MAMMOGRAPHY (FFDM) SYSTEM.

Current openFDA PMA Record#

Device
SECONDLOOK DIGITAL V7.2 CAD
Applicant
Icad, Inc.
PMA number
P010038
Supplement
S016
Product code
MYN
Generic name
Analyzer, medical image
Decision date
2012-11-09
Decision code
APPR
Date received
2012-08-10
Supplement type
Normal 180 Day Track
Supplement reason
Change Design/Components/Specifications/Material
Approval order statement
APPROVAL FOR THE SECONDLOOK DIGITAL V7.2 CAD FOR USE WITH THE PHILIPS MICRODOSE FULL-FIELD DIGITAL MAMMOGRAPHY (FFDM) SYSTEM.